510(k) · Cleared
ClearedEdge Orthopaedics Bite Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icon Orthopaedic Concepts Dba Edge Orthopaedics · HWC Screw, Fixation, Bone
Cleared on Nov 20, 2013 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) and 2 other predicates after a 65-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Nov 20, 2013
- Review
- 65 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K810205 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
- 3 generations backK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- 2 generations backK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
- 1 generation backK100359 Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010
- This deviceK132893 Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810205 | Mecron Cancellous Cannulated Bone Screws | Serrano Intl. | 1981 | — |
| −3 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| −2 | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
| −1 | K100359 | Darco Headed Cannulated Screw | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K132893 | Edge Orthopaedics Bite Compression Screw | Icon Orthopaedic Concepts Dba Edge Orthopaedics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082320 | Darco Small ScrewSummary page 1…s I, 21 CFR 888.3040, Product Code: HWC Panel Code: Orthopedics Predicate Device 121 CFR 807.92(a)(3)J WRIGHflrM Compression Screw (aka DART-FIRE®) - K082320 (Wright Medical Technology) DARCO® Headless Compression Screws - K(080850 (Wright Medical Technology) DARCO® Headed Can… | 2008 |
| * | K080850 | Darco Headless Compression ScrewSummary page 1…redicate Device 121 CFR 807.92(a)(3)J WRIGHflrM Compression Screw (aka DART-FIRE®) - K082320 (Wright Medical Technology) DARCO® Headless Compression Screws - K(080850 (Wright Medical Technology) DARCO® Headed Cannulated Screws - K(100359 (Wright Medical Technology) Description of… | 2008 |
| * | K100359 | Darco Headed Cannulated ScrewSummary page 1…K082320 (Wright Medical Technology) DARCO® Headless Compression Screws - K(080850 (Wright Medical Technology) DARCO® Headed Cannulated Screws - K(100359 (Wright Medical Technology) Description of the Device 121 CFR 807.92(a)(4)1 The EDGE Orthopaedics BITET" Compression Screws inc… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 14 ancestors has a recall.
- 17 other devices also cite its predicate K082320.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only. BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality. Examples of…
Read the full statement (211 words)
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only.
BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality.
Examples of small and long indications for which BITE Compression screws are used:
* Minimally invasive fracture/joint reconstructions
* Multiple-fragment joint fractures
* Simple epiphyseal fractures
o Fractures of the head of the humerus
o Fractures of the head of the tibia
o Cooper fractures of the tibia
o Fractures of the radius
* Fractures of the wrist, ankle, elbow and shoulder
* Scaphoid fractures and other fractures of the hand
* Metatarsal fractures and other fracture of the foot
* Ligament fixation of the proximal humerus
* Ligament avulsion injuries (Apohysis)
* Fractures of small joint bones
o Maleolar fractures
o Navicular fractures
* Fractures of the calcancus and talus
* Arthrodesis of the ankle joint
* Avulsion fracture and metatarsal V
* Fractures of the tarsal region
* Osteotomies
BITE Compression Screws are not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132893 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132893: Edge Orthopaedics Bite Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132893
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026